United States v. Park
Facts
Acme Markets operated a large retail food business, and Park was its president and chief executive officer. FDA inspections of Acme's Baltimore warehouse found rodent infestation and food exposed to contamination, and Park had also previously received a 1970 FDA letter about insanitary conditions at Acme's Philadelphia warehouse. At trial, evidence showed Park delegated sanitation duties to subordinates but retained broad supervisory responsibility, and Park admitted he was responsible for sanitary conditions across the company's operations. The jury was instructed to determine whether Park, by virtue of his position, had authority and responsibility in relation to the conditions that caused the violations.
Issue
Whether the jury instructions in Park's prosecution under 21 U.S.C. § 331(k) were proper under United States v. Dotterweich, and whether the Government had to prove "wrongful action" beyond Park's responsible relation to the violation. The Court also considered whether evidence of the earlier FDA warning letter was admissible.
Rule
Under the Federal Food, Drug, and Cosmetic Act, the Government makes a prima facie case against a corporate officer by introducing evidence sufficient to warrant a finding that, by reason of his position in the corporation, he had responsibility and authority either to prevent the violation in the first instance or promptly to correct it, and that he failed to do so. Criminal liability does not turn on awareness of wrongdoing, but the Act does not require the objectively impossible; a defendant may raise defensively that he was powerless to prevent or correct the violation.
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